US7682385B2 - Artificial valve - Google Patents

Abstract

Method and apparatus implementing and using techniques for controlling flow in a body lumen, including use of an implantable medical device. The device includes a membrane implantable in a body lumen and invertibly deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No. 10/873,052, filed Jun. 22, 2004, now U.S. Pat. No. 7,081,131 issued Jul. 25, 2006, which is a continuation of U.S. application Ser. No. 10/115,557, filed Apr. 3, 2002, now U.S. Pat. No. 6,752,828 issued Jun. 22, 2004, the specifications of which are incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to medical devices for use in a body lumen.

BACKGROUND

A venous valve functions to prevent retrograde flow of blood and allow only antegrade flow of blood to the heart. Referring toFIG. 1A, a healthyvenous valve12 is illustrated in avessel10. The valve is bicuspid, withopposed cusps14. In the closed condition, thecusps14 are drawn together to prevent retrograde flow (arrow16) of blood. Referring toFIG. 1B, if the valve is incompetent, thecusps14 do not seal properly and retrograde flow of blood occurs. Incompetence of a venous valve is thought to arise from at least the following two medical conditions: varicose veins and chronic venous insufficiency.

SUMMARY

This invention relates to medical devices for use with a body lumen. In one aspect, the invention features a medical device including a membrane implantable in a body lumen and invertibly deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen. The membrane can be invertible relative to a radial direction of the body lumen. The membrane can be reversibly deformable between the first position and the second position.

Implementations can include one or more of the following. The membrane can define a portion of a cone, and can include an anchoring element adjacent a vertex of the cone. The membrane can include an anchoring element configured to embed within the body lumen, or alternatively configured to penetrate through the body lumen. The anchoring element may be, for example, a loop or a barb. The membrane can be formed of a polymer, for example, a polyurethane, polyethylene or fluoroplastic.

In another aspect, the invention features a medical system. The system includes multiple membranes, each membrane implantable in a body lumen and invertibly deformable between a first position and a second position. Each membrane is invertible in response to the direction of fluid flow through the lumen.

Implementations of the system can include one or more of the following. The membranes can be symmetrically implantable in the body lumen. Each membrane can be invertible relative to a radial direction of the body lumen and can be deformable by fluid flow in the body lumen. At least one membrane can be reversibly deformable between the first position and the second position. At least one membrane can define a portion of a cone and can include an anchoring element adjacent a vertex of the cone. At least one membrane can include an anchoring element configured to embed within the body lumen or alternatively configured to penetrate through the body lumen. The anchoring element can be, for example, a loop or a barb. At least one membrane can be formed of a polymer, for example, a polyurethane, polyethylene or fluoroplastic.

In another aspect, the invention features a method. The method includes positioning at least one membrane in a body lumen, each membrane invertibly deformable between a first position and a second position. Each membrane is invertible in response to the direction of fluid flow through the lumen.

Implementations of the method can include one or more of the following. The method can include positioning multiple membranes in the body lumen. The multiple membranes can be positioned symmetrically in the body lumen. The method can include penetrating an anchoring element of the at least one membrane through the body lumen or, alternatively, embedding an anchoring element of the at least one membrane into the body lumen.

In another aspect, the invention features a method of controlling flow in a body lumen. The method includes invertibly deforming a membrane between a first position and a second position, the membrane being invertible in response to the direction of fluid flow through the lumen. Implementations can include one or more of the following. The membrane in the second position and a portion of the body lumen can define a cavity. Deformation of the membrane can be relative to a radial axis of the body lumen. The membrane can be deformable by fluid flow in the body lumen. The membrane in the first position and the membrane in the second position can be approximately mirror images of each other. The method can further include invertibly deforming a plurality of membranes.

Embodiments may have one or more of the following advantages. One or more invertible membranes, which can function as artificial valve cusps, can be implanted at a treatment site using a catheter. As such, implantation is minimally invasive and avoids surgery and the possibility of the inherent complications. The membrane is fabricated from a polymer such as a polyurethane, polyethylene or fluoroplastic, which materials are more easily accessible than a natural tissue excised from an animal, and can be manufactured with consistency and efficiency that could be more difficult or more expensive using a natural tissue.

Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIGS. 1A and 1B are illustrations of a venous valve and an incompetent venous valve, respectively.

FIGS. 2A,2B, and2C are partial perspective views of an embodiment of a valve cusp.

FIG. 3 is a cross-sectional view of the valve cusp ofFIG. 2A, taken along line3-3.

FIG. 4 is a cross-sectional view of the valve cusp ofFIG. 2C, taken along line4-4.

FIGS. 5A,5B,5C,5D and5E are schematic views of an embodiment of a method for implanting a valve cusp.

FIGS. 6A and 6B are partial perspective views of an embodiment of a valve cusp.

FIGS. 7A and 7B are partial perspective views of an embodiment of a valve cusp.

FIG. 8 is a cross-sectional view of the valve cusp ofFIG. 7A, taken along line8-8.

FIG. 9 is a cross-sectional view of the valve cusp ofFIG. 7B, taken along line9-9.

FIG. 10 is a partial perspective view of an embodiment of an anchoring element.

FIG. 11 is a partial perspective view of an embodiment of an anchoring element.

DETAILED DESCRIPTION

Referring toFIGS. 2A-2C throughFIG. 4, a pair ofartificial valve cusps30 are illustrated positioned within avessel46, e.g., a vein.Cusps30 can be positioned upstream or downstream relative to an incompetent venous valve, such as the valve shown inFIG. 1B. Eachartificial valve cusp30 includes at least one anchoringelement38 attached to aninvertible portion42, here, an approximately triangular, flexible membrane. Anchoringelement38 is generally configured to hold invertible portion39 at a desired location invessel46. For example, anchoringelement38 can embed itself within awall44 ofvessel46, or penetrate through the wall to securecusp30 to the vessel.Invertible portion42 is capable of deforming between a first position and a second position, e.g., between an opened condition and a closed position, in response to flow of body fluid invessel46 to allow or to reduce the flow in the vessel.

Referring particularly toFIG. 2A andFIG. 3, thecusps30 are shown in a first position in which eachcusp30 forms an approximate semi-cone, such that anopening50 is formed by the curved surfaces of thecusps30. Theopening50 allows antegrade flow of a fluid through the vessel in the direction indicated byarrow48. The membranes ofinvertible portions42 are relatively thin and can conform closely to thevessel wall44 to maximize the size ofopening50. However, eachcusp30 is also held slightly away from thewall44 of thevessel46 by the anchoringelement38, such that agap52 is formed between theinvertible portion42 and thewall44.

Referring particularly toFIG. 2B, retrograde flow of fluid (arrows51) in the vessel can accumulate in thegap52 and exert pressure on theinvertible portion42 of thecusp30. Sinceinvertible portion42 is flexible, it can deform under the exerted pressure and invert to form another approximate semi-cone, as shown inFIG. 2C. That is, eachcusp30 forming a first semi-cone in the first position can invert or flip relative to a radial axis ofvessel46 to form a second semi-cone that is approximately the mirror image of the first semi-cone. As the interior32 of the second semi-cone accumulates retrograde flowing fluid, pressure is exerted on the interior ofcusp30, causing the cusp to move away from thewall44 of the vessel. As a result, thespace53 between the twocusps30 narrows, the size of opening50 decreases, and fluid flow through the vessel and past the cusps is reduced (FIG. 4).

Thecusps30 can remain in the second position until antegrade fluid flow exerts sufficient pressure on the surface ofcusps30opposite interior32 and inverts the cusps to the first position. Thus,cusps30 provide an artificial valve that automatically responds to the flow of fluid or pressure changes invessel46.

FIGS. 5A to 5E show one method of positioningcusps30 at a treatment site invessel46 using acatheter18 that may be delivered into thevessel46 ercutaneously. Thecatheter18 is generally adapted for delivery through thevessel46, e.g., using a guidewire.Catheter18 includes a long, flexible body having acentral portion21, and aretractable sheath22 over the central portion. Referring particularly toFIG. 5B, a cross-sectional view ofFIG. 5A taken along line5-5, twogrooves25 are formed on either side of thecentral portion21, and apush rod28 is positioned inside each of thegrooves25. Eachcusp30 is positioned in agroove25 in a compacted state and held in place by theretractable sheath22 until delivery at the treatment site.

Catheter18 can be delivered to the treatment site using endoprosthesis delivery techniques, e.g., by tracking an emplaced guidewire with central lumen101. At the treatment site, theretractable sheath22 is retracted proximally to form anopening26 at the end of eachgroove25. Referring particularly toFIG. 5C, pushrods28 are used to push each cusp distally toward theopening26 to push theanchoring element38 out of theopening26. Thecusps30 are pushed out of theopenings26 until the anchoringelements38 secure thecusps30 to thewall44 of thevessel46. For example, the anchoringelements38 can embed within thewall44 or penetrate thewall44 and secure to the exterior of thevessel46.

After eachcusp30 is secured to thevessel46, theretractable sheath22 is retracted to fully expose the cusps30 (FIG. 5D). Thecentral portion21 is then pulled proximally past the flexible (and deflectable)cusps30 and retracted from the vessel46 (FIG. 5E). Thecusps30, now secured to thewall44, can deform between the first and second positions, as described above.

Cusps30 are preferably made of a biocompatible material capable of reversible deformation as described above. Eachcusp30 can be formed from a thin, flexible material, such as a polyurethane, polyethylene or fluoroplastic, for example, polytetrafluoroethylene (PTFE).Invertible portion42 can be formed of one or more materials. For example,invertible portion42 may include an edge portion that is relatively more flexible or more compliant than another portion of the invertible portion to help the edges meet and seal when thecusps30 are in the second position.Cusps30 can include a radiopaque material, such as a polymer including a radiopacifier, e.g., tantalum metal or bismuth oxychloride, for positioning and monitoring the cusps.

Similarly, anchoringelement38 is preferably biocompatible. The anchoringelement38 can be formed of a relatively rigid material, such as a polymer having suitable hardness, for example, acrylonitrile-butadiene-styrene (ABS). Other materials can be used, such as metals (e.g., tantalum, tungsten or gold), alloys (e.g., stainless steel or Nitinol), and ceramics. Anchoringelements38 can include a radiopaque material for positioning andmonitoring cusps30. The anchoring element can be embedded in the invertible portion or fixed to a surface of the invertible portion with, for example, adhesive.

OTHER EMBODIMENTS

In other embodiments, any number of cusps can be anchored to thewall44 of thevessel46 to function as a valve for preventing retrograde flow of blood through theblood vessel46. Referring toFIGS. 6A and 6B, asingle cusp60 can be used. Thecusp60 can be10 transported to the treatment site and anchored to thewall44 of avessel46 in the same manner as described above using a catheter. In a first position, thecusp60 forms an approximate semi-cone, with theedges63 of the semi-cone facing thewall44 opposite from where thecusp60 is anchored to thewall44. The interior of the cone forms achannel64 allowing fluid flow past thecusp60. The anchoringelement65 holds thecusp30 slightly away from thewall44 such that agap66 is formed between thecusp60 and thewall44. Retrograde flowing fluid can accumulate in thegap66 and exert pressure on thecusp60, deforming thecusp60 and widening thegap66 until the pressure on thecusp60 inverts the cusp. Referring particularly toFIG. 6B, in an inverted position thecusp60 forms an approximate cone with thewall44 and accumulates retrograde flowing fluid in asack68 formed by the interior of the cone. Accumulated fluid can exert pressure on thecusp60, causing thecusp60 to move away from thewall44. As a result, thespace66 between thecusp60 and thewall44 opposite the anchoring element narrows, until thecusp60 touches thewall44, in a second position as shown. In the second position, flow is reduced past thecusp60 relative to the flow when thecusp60 was in the first position. Thecusp60 remains in the second position until pressure exerted on thecusp60 by the antegrade flow of fluid is sufficient to invert thecusp60 to the first position.

Referring toFIGS. 7A-7B, three cusps70a-70ccan be symmetrically secured to thewall44 of avessel46 in a similar manner as described above. Referring particularly toFIG. 7A, the cusps70a-70care shown in first position that does not substantially impede flow of a fluid through thevessel46. As shown inFIG. 8, the surfaces of the cusps70a-70cconform to thewall44 of thevessel46, allowing asubstantial opening72 for flow past the cusps70a-70c. Each cusp70a-70cis held away from thewall44 by anchoringelements71a-71c, such that agap76 is formed between each cusp and thewall44. As described above, retrograde flowing fluid accumulates in thegap76 and exerts pressure on the cusp70, causing the cusp to deform away from thewall44, until the cusps invert.

Referring particularly toFIG. 7B, in an inverted position the interior of each cusp70a-70caccumulates retrograde flowing fluid. Exerting pressure on the cusps causes them to move toward one another, until the cusps70a-70cmeet in a second position and reduce flow past the cusps70a-70crelative to the when the cusps70a-70care in the first position. Referring toFIG. 9, theopening72 is significantly reduced, thus restricting the fluid flow. The cusps70a-70cremain in the second position until pressure exerted on the cusps70a-70cby antegrade flow of fluid inverts the cusps to the first position.

Although the embodiments above describe a device having one to three cusps, any number of cusps can be used to prevent retrograde flow through a vessel. The cusps can be arranged symmetrically as shown, or can be arranged in any other configuration. Although the embodiments described above included cusps of similar size and configuration, cusps of differing sizes and configurations can be used in conjunction with each other.

The anchoring element can take a number of different forms that permit the end of the cusp to penetrate the wall of a blood vessel and restrain the end of the cusp from re-entering the vessel. For example, the anchoring element can be a barb element, as shown in the embodiments described above. Alternatively, the anchoring element can be a T-hook device80 as shown inFIG. 10, wherein T-hook80 penetrates the wall of a vessel and hooks82 prevent the anchor from re-entering the vessel. In another embodiment, the anchoring element can define aloop84, as shown inFIG. 11, wherein the loopedend86 prevents the anchor from re-entering the vessel.

In other embodiments, a cusp can include more than one anchoring element. A cusp can have other polygonal configurations. For example, a generally rectangular cusp can be secured to a vessel using two anchoring elements adjacent to two corners of the cusp. The cusp can form a semi-cylinder.

Other embodiments are within the scope of the following claims.

Claims (10)

1. A medical device, comprising:

a first frameless membrane not supported by a frame having a first membrane sealing surface; and

a second frameless membrane not supported by a frame having a second membrane sealing surface, the first frameless membrane and the second frameless membrane implantable in a body lumen and deformable between a first position under antegrade fluid flow and a second position under retrograde fluid flow, where in the second position the first membrane sealing surface and the second membrane sealing surface meet to resist fluid flow, and where the first membrane sealing surface and the second membrane sealing surface are formed of a material different from and more flexible than other portions of the first frameless membrane and the second frameless membrane.

2. The medical device ofclaim 1, where the first frameless membrane and the second frameless membrane are symmetrically implantable in the body lumen.

3. The medical device ofclaim 1, where the first frameless membrane and the second frameless membrane each include at least one anchoring element.

4. The medical device ofclaim 3, where the anchoring element is configured to embed within the body lumen.

5. The medical device ofclaim 3, where the anchoring element is configured to penetrate through the body lumen.

6. The medical device ofclaim 1, where the first frameless membrane and the second frameless membrane include a radiopaque material.

7. The medical device ofclaim 1, where the first membrane sealing surface and the second frameless member sealing surface include a radiopaque material.

8. The medical device ofclaim 1, where the first frameless membrane and the second frameless membrane each define a portion of a cone.

9. The medical device ofclaim 8, where the first frameless membrane and the second frameless membrane each include an anchoring element adjacent to a vertex of the cone.

10. The medical device ofclaim 1, where the first frameless membrane and second frameless membrane move from the second position to the first position when antegrade fluid flow exerts a sufficient amount of pressure on the first frameless membrane and second frameless membrane.

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